Concomitant Tracheostomy and Lung Resection
|ClinicalTrials.gov Identifier: NCT01053624|
Recruitment Status : Unknown
Verified January 2011 by University Hospital, Clermont-Ferrand.
Recruitment status was: Recruiting
First Posted : January 21, 2010
Last Update Posted : January 19, 2011
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Procedure: Tracheostomy||Phase 3|
Background: Respiratory failure after lung resection is a major complication. Several studies suggest that low predictive postoperative pulmonary function is a predictive factor of mechanical ventilation (MV). In critically ill patients requiring MV, early tracheostomy may shorten the duration of MV and length of stay in intensive care.
Study objective: To determine whether concomitant tracheostomy (CT) would decrease the length of MV and improves outcome in patient with predictive postoperative forced expiratory volume in 1 second (FEV1ppo) < 50%. We call CT a tracheostomy performed immediately after the lung resection under the same general anesthesia.
Method: An open monocentric randomized controlled trial has been design. Inclusion and exclusion criteria are mentioned below. FEV1ppo will be calculated by the mean of the scintigraphic method for pneumonectomy and by the mean of the number of resected segments for lobectomy and segmentectomy. Randomization will be made the day before the operation. The procedure will be an open surgical tracheostomy. A daily data base will be completed from randomization until discharge. The primary and secondary criteria are mentioned below.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Concomitant Tracheostomy and Lung Resection in Patient With Low Postoperative Pulmonary Function|
|Study Start Date :||October 2001|
|Estimated Primary Completion Date :||June 2010|
|Estimated Study Completion Date :||June 2010|
- number of mechanical ventilation days after operation until discharge [ Time Frame: 2 months ]
- 60 days mortality rate [ Time Frame: 2 months ]
- ICU length of stay [ Time Frame: 2 months ]
- hospital length of stay [ Time Frame: 2 months ]
- cumulative incidence of postoperative respiratory complications defined as pneumonia, re-ventilation, atelectasis needing fiberbronchoscopy, non cardiogenic pulmonary edema, air leakage >7 days, broncho-pleural fistula, pulmonary embolism, empyema [ Time Frame: 2 months ]
- cumulative incidence of postoperative cardiac complications defined as arrythmia needed treatment, cardiac failure needing inotrop drug, acute coronary stroke [ Time Frame: 2 months ]
- laryngeal and tracheal complications [ Time Frame: 2 months ]
- general complications [ Time Frame: 2 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01053624
|Contact: Patrick Lacarin||04 73 75 11 firstname.lastname@example.org|
|Clermont-Ferrand, France, 63003|
|Contact: Patrick Lacarin 04 73 75 11 95 email@example.com|
|Principal Investigator:||Marc Filaire, MD||University Hospital, Clermont-Ferrand|